General provisions

This is a continuation course to Pre-clinical safety assessment and pharmacovigilance (3FX011 or 3FX211) 7.5 credits and Adverse drug reactions and pharmacovigilance (3FX200 or 3FX201), 7.5 credits.

Participating unit: the Uppsala Monitoring Centre (UMC) within WHO.

Entry requirements

Optional 2.5 credits from Preclinical Safety Assessment and Pharmacovigilance, or Adverse Drug Reactions and Pharmacovigilance, 7.5 credits

Learning outcomes

On completion of the course the student should be able to:

• Search, compile, analyse and evaluate reports about adverse drug reactions in scientific literature and databases.
• Explain the importance of pharmacogenomics for individual variation in adverse drug reactions.
• Analyse methods for pharmacovigilance.
• Analyse and assess warnings, risk management and risk communication about adverse drug reactions.
• Analyse and assess the effects and safety of drugs.
• Give an account for pharmacovigilance from a regulatory perspective.
• Write scientific and popular text in proper English.

Content

The course focus on how to compile, analyse and assess the effect and safety of drugs as well as pharmacovigilance. Examination is based on written tests and assignments. During the course, the student will train oral and written presentation in groups and individual written presentation.

Instruction

The course is Internet-based, and the teaching is given as half-time studies. All teaching is given in English. Strong emphasis is placed at the student's ability to acquire, process and communicate scientific material about the effect and safety of drugs. A web-based learning management platform will be used in the teaching and for communication between participants and teacher. Mandatory parts are start of the course, assignments and written essay assignment. The course contains no compulsory physical meetings. This assumes that the participants have access to an Internet-connected computer and additional equipment according to instructions from the department.

Assessment

Examination takes place at the end of the course. Passing the course requires, an approved test (examination code), passed results of web seminars (examination code) and written advanced assignment (examination code). A chance to carry out a failed compulsory part can be arranged only at the next course occasion and only in case of a vacancy. Each student has the right to six examinations (one examination and five re-examinations).